Objective: To assess the feasibility, safety, and efficacy of a novel fully covered radioactive stent for the treatment of advanced esophageal and gastric cardia cancer. Methods: Data of 122 patients, who underwent esophageal radioactive stent placement for advanced esophageal or gastric cardia cancer between January 2012 and September 2017 in Zhongda Hospital, were retrospectively analyzed. Patients were divided into the novel stent group (n=59; 45 males, 14 females; mean age 73±10 years old) and the conventional stent group (n=63; 51 males, 12 females; mean age 72±9 years old), according to the types of radioactive stents. No significant difference was found between the two groups in baseline characteristics (all P>0.05). Outcomes were measured in terms of technical success, dysphagia score, stent restenosis, stent migration, major complications, and overall survival. Results: The technical success rate was 98.3% in the novel stent group, and 100.0% in the conventional stent group (P=0.484) . The dysphagia scores 3 days after surgery decreased from 3.27±0.45 and 3.37±0.49 to 1.25±0.66 and 1.32±0.50, respectively (all P<0.01), and the variances were comparable (P=0.709). Compared with conventional stents, novel stents were significantly associated with a decreased in the rate of stent restenosis, 11.9% vs 27.0%; cause-specific hazard ratio 0.387, 95%CI 0.160-0.934 (P=0.035); sub-distributional hazard ratio 0.401, 95%CI 0.167-0.963 (P=0.041), while the stent migration rate was statistically comparable (13.6% vs 6.3%, P=0.181). There was no significant difference between the novel stent group and the conventional stent group in major complications (all P>0.05), including moderate-severe chest pain (22.0% vs 25.4%), hemorrhage (11.9% vs 11.1%), fistula formation (1.7% vs 4.8%), and aspiration pneumonia (5.1% vs 6.3%). The median overall survival was 146(95%CI 115-177) days in the novel stent group, and 147(95%CI 98-196) days in the conventional stent group, and no significant difference was found (P=0.967). Conclusions: In patients with advanced esophageal or gastric cardia cancer,placement of a novel fully covered radioactive stent is safe and effective. This novel stent can relieve dysphagia rapidly and prevent stent restenosis effectively.
目的： 评估新型全覆膜内照射支架用于治疗中晚期食管和贲门癌的可行性、安全性和有效性。 方法： 回顾性分析2012年1月至2017年9月于东南大学附属中大医院接受食管内照射支架置入术治疗中晚期食管或贲门癌的122例病例资料。按支架类型分为新型支架组[59例，男45例、女14例，平均年龄（73±10）岁]和普通支架组[63例，男51例、女12例，平均年龄（72±9）岁]。两组间各基线特征差异均无统计学意义（均P>0.05）。评估指标包括：技术成功率、吞咽困难评分、支架再狭窄、支架移位、主要并发症和生存时间。 结果： 新型支架组和普通支架组技术成功率分别为98.3%（58/59）和100.0%（63/63）（P=0.484）；术后3 d的吞咽困难评分分别由术前的3.27±0.45和3.37±0.49降至1.25±0.66和1.32±0.50（均P<0.01），变化幅度差异无统计学意义（P=0.709）。新型支架组支架再狭窄率显著低于普通支架组（11.9%比27.0%），原因别风险比0.387，95%CI：0.160~0.934（P=0.035）；部分分布风险比0.401，95%CI：0.167~0.963（P=0.041），两组支架移位率差异无统计学意义（13.6%比6.3%，P=0.181）。新型和普通支架组的主要并发症包括中重度胸痛（22.0%比25.4%）、食道出血（11.9%比11.1%）、瘘道形成（1.7%比4.8%）和吸入性肺炎（5.1%比6.3%），其差异无统计学意义（均P>0.05）。新型和普通支架组中位生存时间分别为146（95%CI：115~177）和147（95%CI：98~196）d，差异无统计学意义（P=0.967）。 结论： 新型全覆膜内照射支架用于治疗中晚期食管和贲门癌安全、有效，该支架能快速缓解吞咽困难症状且有效预防支架再狭窄。.
Keywords: Cardia; Esophageal neoplasms; Iodine radioisotopes; Self-expandable metallic stent.